Financial Assistance Value for Equitable Access to Specialty Medications for Adults With Multiple Sclerosis Using Health System Pharmacy Services

Multiple sclerosis (MS) is a debilitating neurodegenerative disease that will significantly decrease a patient's quality of life if not properly managed.²  The various disease-modifying therapies (DMTs) currently available contribute to treatment heterogeneity within the MS space.³  In addition, general consensus on treatment approach is lacking; therefore, patient preference after review of safety, tolerability, cost, lifestyle, efficacy, and adverse effects (AEs) are the driving factors of treatment selection. However, the financial burden of MS medication must be recognized.^2–4  Pharmaceutical costs make up almost 70% of total health care costs for patients with MS, compared with national averages of 10% to 15% for the general population.⁵  Within a 10-year period (2006-2016), reported out-of-pocket costs for low-income Medicare Part D beneficiaries increased from $372 to $2673 annually, a 7.2-fold increase.⁴  In 2018, Medicare reported $4.9 billion in total spending on self-administered MS DMTs through Medicare Part D, with an additional $760 million spent on MS DMT infusions through their Medicare Part B program.⁵  Because patients with out-of-pocket drug costs under $250 per month are less likely to abandon their treatment regimen,⁶  the high out-of-pocket costs of MS DMTs may very well limit access to therapy and cause delays in starting treatment, as expensive medications have been associated with nonadherence.^2–4,6  Almost half of patients with MS who responded to a recent survey reported nonadherence to a treatment regimen or reduction of other household spending because of the high cost of their DMT.⁵  Poor adherence to DMTs is associated with higher rates of MS relapse, hospitalizations, emergency department visits, and overall medical costs.⁵ 

University of Rochester (UR) Medicine has a fully integrated health system specialty pharmacy (HSSP). The specialty pharmacy has 2 pharmacists and 2 medication access specialists (MASs) integrated into the neurology clinic. Primarily, the MS pharmacists provide comprehensive medication management services, which include medication education and routine follow-up for adherence, safety, and efficacy monitoring. In addition, the HSSP team helps secure co-pay assistance funding through drug manufacturer patient assistance programs (eg, co-pay assistance cards), independent grant foundation support, state programs, and internal facility funding provided by the hospital's social work department. The MAS team in the neurology clinic assists with securing similar co-pay assistance funding that is available for patients who are prescribed an infused DMT that is not dispensed by the UR specialty pharmacy. This team also facilitates the initiation of all high-cost MS specialty medications and works closely with the HSSP during this process.

The goal of this study is to evaluate the financial burden of MS therapy for patients and its resolution through the integrated specialty pharmacy and the MAS team. The data collected will be used to evaluate and demonstrate the current practice of the UR Specialty Pharmacy and UR MS Center MAS team in obtaining financial assistance for patients in our MS clinic.

This single-center, retrospective chart review was granted an exemption by the UR Research Subjects Review Board. Data were collected from the electronic medical record and pharmacy dispensing software.

Included in the study were patients receiving financial assistance for an MS medication (BOX) prescribed through the UR MS Center and filled a self-administered medication through the integrated HSSP or received an infused DMT at the UR MS Center between July 20, 2020, and July 20, 2022. Prescriptions were excluded if they were filled at an outside specialty pharmacy or obtained directly through manufacturer's patient assistance programs. Prescription fills were also excluded if financial assistance was billed but not needed due to complete coverage from insurance.

The primary objective of this study is to quantify the amount of financial assistance obtained for patients with MS by pharmacy staff integrated within the health system through the use of internal facility funds, New York State Elderly Pharmaceutical Insurance Coverage (NYS EPIC), independent grant foundations, and manufacturer co-pay assistance. In addition, we evaluated financial assistance used for each medication, grouping into 1 category both the brand-name and generic product.

The MAS program integrated within the neurology department facilitates access to specialty medications and outpatient clinic-administered therapies while maximizing the revenue and margin associated with the provision of these high-cost medications through retention of supply chain management within Strong Memorial Hospital, a part of the UR health system. When a clinician decides to start a patient on a new therapy, they notify the MAS team who then works with the patient and provider to complete the necessary paperwork required by the drug manufacturer, financial assistance programs, and the institution. After the necessary forms are completed, the team collaborates with the institution's prior authorization (PA) specialist and the insurance company to review the coverage and benefit details and enrolls the patient in available financial assistance services.

For patient safety and workflow efficiency, our preference is to purchase directly from the wholesaler (buy and bill) all infused therapeutic agents administered in the clinic rather than getting medication from nonintegrated pharmacies (white bagging), although we do face the occasional hurdle from payers that put a restriction on this. For plans that do not allow us to buy and bill, the MAS team coordinates the ordering, shipping, and distribution and ensures that claims are marked to bill appropriately. Once our MAS team is notified of a patient who is starting therapy, the patient is put on a tracker that allows the team to monitor insurance changes, claim management, and any assistance programs used; this ensures that the hospital is reimbursed appropriately.

The UR Specialty Pharmacy provides services to numerous clinical specialties, including neurology. If the HSSP determines that insurance requires a PA for a new prescription, the pharmacist notifies the neurology division PA specialist to complete the process. When the PA is approved, or if an authorization is not required, the prescription undergoes a benefits investigation to determine whether the UR Specialty Pharmacy will be able to fill the medication, as some insurance plans impose restrictions related to which pharmacies may be used. If the UR Specialty Pharmacy is unable to fill the medication, the pharmacy will inform the neurology MAS team, who continue the financial assistance process with the patient and the external specialty pharmacy.

If the UR Specialty Pharmacy can fill the medication, patients are enrolled in the UR MS Clinical Patient Management Program. Participation in this program includes medication education, administration and AE management counseling, medication delivery, refill reminders, adherence assessments, medication reconciliation, efficacy monitoring, medication interaction reviews, and safety monitoring. This program also includes an investigation into financial assistance options based on several factors, including the patient's insurance plan and financial status. Patients with commercial insurance have the option to be enrolled in manufacturer co-pay assistance. If eligible, patients with Medicare Part D will be enrolled in NYS EPIC in addition to being signed up for independent foundation grants. In all cases, the UR Specialty Pharmacy will help with financial assistance to ensure a comprehensive, accurate, and seamless process. In cases where the aforementioned steps have been completed and co-pays remain unaffordable, the UR Specialty Pharmacy may use internal facility funds through the social work voucher program for short-term assistance to provide access to essential therapies.

Data were analyzed using descriptive statistics. No missing data were identified during the collection process.

During the study period, the UR MS Center saw 2923 patients with MS, of whom 2665 were prescribed a self-administered MS DMT or dalfampridine, and 1130 were prescribed an infused DMT. The UR Specialty Pharmacy currently serves over 600 patients receiving self-administered MS specialty medications. The neurology MAS team currently manages approximately 900 patients receiving MS DMT infusions at the UR MS Center. A total of 6345 claims for 668 individuals were included in this study. Because no financial assistance was used for 355 claims and 5 patients due to insurance coverage changes during the time frame, these were excluded from the report. Through the MS Center, 265 patients received an infused DMT and generated a total of 867 claims. Through the HSSP, 398 patients received a self-administered medication and generated a total of 5123 claims.

Patients received a total of $3,377,172.96 in financial assistance over 2 years. The median financial assistance used per patient per day of medication coverage was $2.08 (IQR, 12.02). The median patient out-of-pocket cost per patient per day after financial assistance was $0 (IQR, 0). Manufacturer co-pay assistance provided the most financial support overall with a total of $2,404,883.31, followed by independent grant foundations providing $574,659.27. The internal facility funds and the NYS EPIC program provided $241,377.97 and $156,252.41, respectively (FIGURE). The median assistance per patient per day of coverage was $1.97 (IQR, 11.70) from manufacturer programs, $7.37 (IQR, 12.57) from grant foundations, $9.21 (IQR, 13.35) from internal facility funds, and $10.41 (IQR, 3.66) from the NYS EPIC program. Commercially insured patients received a total of $2,458,559.81 in assistance, and Medicare-insured patients received a total of $907,382.57 in assistance. The median assistance per patient per day of medication coverage was $1.29 (IQR, 2.24) for commercially insured patients and $11.00 (IQR, 9.35) for Medicare-insured patients.

The total financial assistance obtained for patients utilizing the internal HSSP was $2,288,475.34, with a median total assistance used per patient per day of medication coverage of $1.96 (IQR, 11.13). Those getting infusions at the UR MS Center received a total of $1,088,697.62 in financial assistance with a median total assistance used per patient per day of medication coverage of $4.45 (IQR, 31.30). The median patient out-of-pocket cost per day of medication coverage for those using the HSSP and the infusion center was $0 (IQR, 0) and $0.03 (IQR, 0.06), respectively.

The majority of financial assistance obtained was for patients who received ocrelizumab with a total of $759,053.20, and the median assistance per patient per day of medication coverage was $5.56 (IQR, 24.08), followed by glatiramer acetate (total $537,140.49; median $1.29, IQR, 9.76) and teriflunomide (total $410,418.05; median $12.82, IQR, 12.23). Interferon beta-1b had the highest median assistance per patient per day of $21.30 (IQR, 26.71; TABLE).

This study showed that the UR integrated pharmacy services saved patients substantial out-of-pocket expenses. These services help to identify those in need of financial assistance and streamlines the process for enrolling patients in various programs. Although there are many patients prescribed a DMT or dalfampridine through our MS clinic, they are not all in need of or eligible for financial assistance. In fiscal year (FY) 2020, the payer mix within the department was 7.6% on Medicaid and 46.3% on Medicare plans. This meant that 53.9% of patients did not qualify for a manufacturer co-pay assistance program due to the federally mandated Anti-Kickback Statute, which does not allow manufacturers to “knowingly and willfully offer, pay, solicit, or receive any remuneration to induce or reward the referral or generation of business reimbursable by any [f]ederal health care program.”⁷  Likewise, in FY 2021, 7.2% of patients were on Medicaid and 45.5% were on Medicare, for a total of 52.7%. In addition, there were some patients who were ineligible for the integrated HSSP service because some commercial insurance plans require use of an outside specialty pharmacy.

The high cost of MS medications can prohibit patients from obtaining their DMTs, which can lead to nonadherence and treatment delays. Medicare claims data demonstrated a higher likelihood of earlier DMT initiation when patients were eligible for a subsidy program, compared with those who were not eligible.⁸  Various studies evaluating the role and impact of HSSP services on the care of patients with MS have demonstrated improved outcomes, including high DMT adherence and persistence.⁹  A multisite study of 4 HSSPs evaluating patient-reported outcomes and pharmacist actions found that patients with noncommercial insurance were more likely to report impacted productivity (eg, missed work, school, or planned activities), which resulted in more pharmacist actions.¹⁰  In our study, patients with Medicare insurance required a significant amount of financial assistance. These patients are not eligible for manufacturer co-pay assistance and must rely on independent grants that are only available intermittently throughout the year when funding is available and have a lengthy application process. HSSPs and integrated pharmacy MAS services are essential to assist patients with this process, especially those with impacted productivity who may not be able to apply on their own and could lose out on the funding opportunity.

Beyond our own study, an individual approach to cost counseling and financial navigation has been shown to decrease costs. A randomized controlled study showed financial services may decrease patient hardship and worry while improving satisfaction and treatment adherence compared with those who do not have these services.¹¹  While patient-reported outcomes were not within the scope of our study, financial worry, along with increasing cost-related care, has been associated with nonadherence.¹²  In addition to pharmacy services reducing patient out-of-pocket costs, they also provide financial benefit in potential cost savings through interventions such as DMT selection, safety monitoring and AE management.¹³  If the most appropriate treatment is given, then AEs can be avoided, which, ultimately, reduces overall health care costs.¹³ 

When developing a service to navigate financial assistance for patients, it is important to note that insurance policies have varying differences in terms, conditions, and models of cost-sharing structures. Outpatient infusion drugs should fall under the patient's medical benefit, whereas drugs that are take-home specialty medications should fall under the pharmacy benefit. Some insurance plans have separate deductibles for medical services and pharmacy services, meaning the patient would need to meet 1 deductible for medically billed services (infusions) and a different deductible for pharmacy (prescription) expenses. There are other plans where the pharmacy and medical benefit share a deductible, meaning all the medically billed services and prescription drug expenses count together toward 1 deductible. It is important to be aware of the various needs and types of financial assistance available and keep communication open between the clinical team and the assistance providers.

The median assistance per patient per day was higher for infused medications; however, this could be due to the medication dosing schedule of certain infusions having a shorter time frame of coverage. For example, the first infusion of ocrelizumab is followed by a second infusion 2 weeks later. When a patient has a high-deductible plan, a large amount of assistance may only be needed for the initial 2 weeks of medication coverage as subsequent infusions may be covered once the deductible was met. In contrast, prescriptions dispensed through the HSSP were primarily for a 1 month supply of medication. Using the calculation of cost per day allows for a clear comparison among the self-administered specialty medications that have a similar day supply of medication but may be more difficult to directly compare with the infused medications. It is also worth noting the variation in the number of claims for each medication when looking at these values. For instance, although the interferon beta-1b claims had the highest median assistance per patient per day of medication coverage in our study, this included only 2 patients and 5 claims; thus, it may not be an accurate representation of overall patient costs for this medication. During the time frame for this study, some medications were available as generics, including glatiramer acetate and dimethyl fumarate, which may have impacted the amount of financial assistance used for these medications, as some insurance plans have lower co-pays for generic products. However, if a patient has a high deductible, they may need more grant or internal facility fund assistance because most co-pay assistance programs from generic manufacturers tend to be less comprehensive, reliable, and readily available as brand-name manufacturer programs.

Throughout the research process, we identified several limitations. The results shared here are from a single MS center, so we do not have comparators. If a patient did not use co-pay assistance, their data were not pulled and, hence, we were unable to make a comparison of overall co-pays for all patients receiving specialty medications through our programs. We also did not have access to medication co-pay data at other institutions; therefore, we could not compare our patients’ co-pays to those made at other specialty pharmacies and infusion centers. Subsequently, the lack of comparator groups limited the patient population included in these data. Patient access limitations due to insurance restrictions also reduced our patient population. Finally, using this data collection approach did not allow us to calculate treatment adherence rates for our patient population, which is an objective we would like to investigate in future research.

Further, incorrectly billed and rebilled infusion medication claims do not always land in the MAS work queue, so some patient accounts may be missing from this data set. Any number of the infusion medication charges and claims could also be associated with human error and incorrect coding. Some denied claims that were sent for additional processing within the billing team may not drop into the work queue. Some patients voluntarily chose to not enroll in these services and some patients may have an insurance change that the MAS team is unaware of, so they have not received the benefits of these programs.

Future areas of research might look at the frequency and amount of co-pay assistance obtained for patients across all pharmacy services and patient assistance programs for DMTs and compare those findings with the results of our study. In addition, evaluating financial assistance, patient out-of-pocket costs, patient demographics, and treatment adherence rates could be helpful in demonstrating the need for and value of these pharmacy services.

To our knowledge, this study is the first of its kind to quantify financial assistance obtained for specialty medications for patients with MS. Patients at this MS center were able to save thousands of dollars in out-of-pocket MS specialty medication expenses via various types of financial assistance. Integrated HSSPs and MAS teams are a valuable resource that can help reduce out-of-pocket MS specialty medication costs, which may improve access to these medications.

The authors thank Allison Trawinski and Peggy Aunginer for their support on this project and for reviewing this manuscript.